Soft suture-based anchors

ABSTRACT

Suture constructs and methods for soft tissue to bone repairs. The suture construct is a soft, suture-based anchor which is self-cinching and has a specific, accordian-type configuration (i.e., with the ability to fold from a first, extended position to a second, folded or compressed position). The suture-based anchor may be formed essentially of a flexible material such as a high strength surgical suture, suture chain, or suture.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 15/242,331,filed Aug. 19, 2016, now U.S. Pat. No. 10,595,845, which is acontinuation of U.S. patent application Ser. No. 13/624,321, filed Sep.21, 2012, now U.S. Pat. No. 9,421,008, which claims the benefit of U.S.Provisional Application No. 61/538,163, filed Sep. 23, 2011, thedisclosures of which are incorporated by reference in their entiretiesherein.

FIELD OF THE INVENTION

The present invention relates to the field of surgery and, moreparticularly, to a joint or ligament reconstruction technique andassociated fixation and reconstruction device.

BACKGROUND OF THE INVENTION

When soft tissue such as a ligament or a tendon becomes detached from abone, surgery is usually required to reattach or reconstruct the tissue.Often, a tissue graft is attached to the bone to facilitate regrowth andpermanent attachment. Techniques and devices that have been developedgenerally involve tying the soft tissue with suture to an anchor or ahole provided the bone tissue. Knotless suture anchors, such as the twopiece Arthrex PushLock® anchor, disclosed in U.S. Pat. No. 7,329,272,have been developed to facilitate tissue fixation to bone.

It would be desirable to provide a suture construct which has a designthat allows tensioning of the construct as necessary and upon insertioninto bone. Also needed is a suture construct that may be knotless andthat is formed essentially of a soft material such as suture (orsuture-based materials or other soft materials and/or compositions) withthe ability to be inserted into a bone socket and then tightened bysimple traction on one of the suture strands.

SUMMARY OF THE INVENTION

The present invention provides a suture construct for fixation of softtissue to bone with the ability to tension/retension the sutureconstruct. The suture construct may be a knotted or a knotlessconstruct.

The suture construct of the present invention is a soft, suture-basedanchor which is self-cinching and has a specific, accordion-typeconfiguration (i.e., with the ability to fold from a first, extendedposition to a second, folded or compressed position). The suture-basedanchor may be formed essentially of a flexible material such as suture(for example, FiberWire® suture) or suture chain (such as FiberChain®)or suture tape (such as FiberTape®), to form a SutureLock™, ChainLock™or TapeLock™ suture-based anchor, respectively.

A suture (such as FiberWire®) may be employed to form a SutureLock™anchor. Another suture (for example, a TigerWire® suture) is firstpassed through a length of the FiberWire® through multiple points suchthat the TigerWire® circles back to exit through the FiberWire® near thespot where it entered (in a suture-through-suture technique), creating aloop that penetrates the suture in a “sine-wave” configuration.Tensioning the two free ends of the TigerWire® tightens the loop and“accordionizes” the suture, creating expansion of the SutureLock™ anchorto create an interference fit. The SutureLock™ anchor is inserted into abone socket/tunnel and the tails of the TigerWire® are tensioned to“accordionize” the FiberWire® (i.e., to fold or compress the FiberWire®to achieve an “accordion-like” shape). Additional sliding sutures may beadded (threaded) through the soft anchor (SutureLock™ anchor) so thatthe soft anchor becomes double-loaded, triple-loaded, etc., i.e.,multiple-loaded, as desired and depending on the specificcharacteristics of each surgical repair.

A suture chain (such as FiberChain® or FiberLink®) may be employed toform a ChainLock™ anchor. A free end of the suture chain (FiberChain®)is first passed through the chain (for example, through every other linkin the chain) so that, when the free end is tightened, it collapses thechain in an accordion-like fashion with laterally-projecting links toproduce an interference fit. The loop is closed down by pulling tensionon the tail and this collapses the link like an accordion, forming theChainLock™ anchor (i.e., folding or compressing the FiberChain® toachieve an “accordion-like” shape). A flexible strand (for example, aFiberWire®) is threaded through a middle link of the accordion. Thisflexible strand acts as the sliding suture for tissue fixation after theanchor is placed into bone. Once the ChainLock™ anchor is inserted intothe bone socket/tunnel, the sliding suture (FiberWire®) is tensioned sothat the tail of the FiberChain is flush with the bone after tensioning.Additional sliding sutures may be added (threaded) through the softanchor (ChainLock™ anchor) so that the soft anchor becomesdouble-loaded, triple-loaded, etc., i.e., multiple-loaded, as desiredand depending on the specific characteristics of each surgical repair.

A suture tape (such as FiberTape®) may be employed to form a TapeLock™anchor. A FiberWire® suture is first passed through a length of theFiberTape® such that the FiberWire® circles back to exit through theFiberTape® near the spot where it entered, creating a loop thatpenetrates the tape in a “sine-wave” configuration. Tensioning the twofree ends of the FiberWire® tightens the loop and “accordionizes” thesuture tape (i.e., folding or compressing the FiberTape® to achieve an“accordion-like” shape), creating expansion of the TapeLock™ anchor tocreate an interference fit. The TapeLock™ anchor is inserted into a bonesocket/tunnel and the tails of the FiberWire® are tensioned to“accordionize” the FiberTape® (i.e., to fold or compress the FiberTape®to achieve an “accordion-like” shape). Additional sliding sutures may beadded (threaded) through the soft anchor (TapeLock™ anchor) so that thesoft anchor becomes double-loaded, triple-loaded, etc., i.e.,multiple-loaded, as desired and depending on the specificcharacteristics of each surgical repair.

These and other features and advantages of the invention will be moreapparent from the following detailed description that is provided inconnection with the accompanying drawings and illustrated exemplaryembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a suture-based anchor (SutureLock™ anchor) accordingto an exemplary embodiment of the present invention.

FIG. 2 illustrates the suture-based anchor (SutureLock™ anchor) of FIG.1 secured in bone with a pusher (a ring-handed instrument).

FIG. 3 illustrates the suture-based anchor (SutureLock™ anchor) of FIG.2 with at least one tail of the suture tensioned, to accordionize thesuture-based anchor (SutureLock™ anchor), so that the suture is flushwith the inner cortex of the bone after tensioning.

FIG. 4 illustrates a suture-based anchor (ChainLock™ anchor) accordingto another exemplary embodiment of the present invention.

FIG. 5 illustrates the suture-based anchor (ChainLock™ anchor) of FIG. 4with a FiberWire threaded through a middle link and with one tail of thesuture chain tensioned.

FIG. 6 illustrates the suture-based anchor (ChainLock™ anchor) of FIG. 5secured in bone with a pusher (a ring-handed instrument).

FIG. 7 illustrates the suture-based anchor (ChainLock™ anchor) of FIG. 6with a tail of the suture chain tensioned, to accordionize thesuture-based anchor (ChainLock™ anchor), so that the suture chain isflush with the inner cortex of the bone after tensioning.

FIG. 8 is an enlarged view of the pusher (ring-handed instrument) ofFIG. 6 .

FIG. 9 illustrates a suture-based anchor (TapeLock™ anchor) according toyet another exemplary embodiment of the present invention (with aFiberWire® suture passed through the length of a suture tape).

FIG. 10 illustrates the suture-based anchor (TapeLock™ anchor) of FIG. 9with the two free ends of the FiberWire® suture tightened toaccordionize the suture tape.

FIG. 11 illustrates the suture-based anchor (TapeLock™ anchor) of FIG.10 secured in bone with a pusher (a ring-handed instrument).

FIG. 12 illustrates the suture-based anchor (TapeLock anchor) of FIG. 11with the tails of the FiberWire tensioned, to accordionize thesuture-based anchor (TapeLock anchor) so that the suture tape is flushwith the inner cortex of the bone after tensioning.

FIGS. 13(a)-(d) illustrate subsequent steps of a method ofself-reinforcing knotless fixation of soft tissue with a suture-basedanchor of the present invention, and according to an exemplary method ofknotless fixation of the present invention.

FIGS. 14(a)-(e) illustrate subsequent steps of another method ofself-reinforcing knotless fixation of soft tissue with a suture-basedanchor of the present invention, and according to another exemplarymethod of knotless fixation of the present invention.

FIG. 15 illustrates a folding tube suture anchor according to anotherexemplary embodiment of the present invention.

FIG. 16 illustrates the folding tube suture anchor of FIG. 15 tensioned.

FIGS. 17-21 illustrate subsequent steps of folding the tube anchor ofFIG. 15 .

FIG. 22 illustrates a soft anchor implant for soft tissue repairsaccording to another embodiment of the present invention.

FIGS. 23(a) and (b) illustrate a soft anchor implant for soft tissuerepairs according to another embodiment of the present invention.

FIG. 24 illustrates a soft anchor implant for soft tissue repairsaccording to another embodiment of the present invention.

FIG. 25 illustrates a soft anchor implant for soft tissue repairsaccording to another embodiment of the present invention.

FIGS. 26(a)-(c) illustrate subsequent steps of forming the soft anchorimplant of FIG. 22 .

FIG. 27 illustrates another view of the soft anchor implant of FIG. 25 .

FIGS. 28-33 (a) and 33 (b) illustrate methods of tissue fixation with asoft anchor implant of the present invention.

FIGS. 34-41, 42 (a), 42(b), and 43-45 illustrate other methods of tissuefixation with soft anchor implants of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The present invention provides surgical systems and methods for knottedor knotless soft tissue (ligament, tendon, graft, etc.) repair andfixation, such as fixation of soft tissue to bone. The suture anchor ofthe present invention is a suture-based anchor with a body that consistsessentially of a flexible material such as suture, high-strength suturesuch as FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234), suturetape such as FiberTape® (disclosed in U.S. Pat. No. 7,892,256), suturechain such as FiberChain® (disclosed in U.S. Pat. No. 7,803,173), amongothers, or combination of these materials. The body of the flexiblematerial forms a loop that closes down and collapses the loop like anaccordion. Once the suture anchor is placed into a bone socket ortunnel, tails of the anchor are tensioned to allow the loop of flexiblematerial to “accordionize” and to create an interference fit.

Referring now to the drawings, where like elements are designated bylike reference numerals, FIGS. 1-12 illustrate exemplary softsuture-based anchors 90, 100, 200 of the present invention that areprovided with a specific, accordion-type configuration. The suture-basedanchors 90, 100, 200 may be formed essentially of a flexible materialsuch as suture (for example, FiberWire® suture) or suture chain (such asFiberChain®) or suture tape (such as FiberTape®), to form a SutureLock™,ChainLock™ or TapeLock™ suture-based anchor, respectively.

FIG. 1 illustrates suture-based anchor 90 (SutureLock™ anchor 90) formedessentially of a flexible strand 10 (for example, a suture such as aFiberWire® suture 10). Another flexible strand 11 (for example, anotherFiberWire® or TigerWire® suture 11) is passed through the length of theFiberWire® 10 (with a needle, for example) in a suture-through-suturetechnique. The flexible strand 11 (TigerWire® suture 11) is preferably acolored flexible strand or suture (or colored differently from theflexible strand 10) to allow easy differentiation between the strandsand to allow medical personnel (e.g., surgeon) to distinguish betweenthe sutures. The TigerWire® 11 circles back to exit through theFiberWire® 10 near the spot where it entered, creating a loop 15 thatpenetrates the suture in a “sine-wave” configuration. The flexiblestrand 11 (TigerWire® suture 11) may be passed through the suture 10 atdifferent locations and as desired, for example, at predeterminedinsertion points on the length of the suture 10 (such as six locations,for example), which may be equally spaced from each other or from atleast some of the remaining insertion points, or which may not beequally spaced relative to the other insertion points. The end of theTigerWire® suture 11 is brought back to reenter the FiberWire 10 nearthe spot where it first entered, to close the FiberWire® 10 and formclosed loop 15.

When the two free ends of flexible strand 11 (TigerWire® suture 11) aretightened (as shown in FIGS. 2 and 3 ), the FiberWire® 10 is“accordionized” and the loop 15 collapses in an accordion-like fashionwith laterally-projecting links to produce an interference fit. The loop15 is closed down by pulling tension on the tails and this tensioncollapses the suture like an accordion, forming the SutureLock™ anchor90.

FIGS. 2 and 3 illustrate the insertion of the SutureLock™ anchor 90 intoa bone socket/tunnel 30 employing a pusher 50 (a ring-handed instrument)provided with a ring 52 and a forked tip 55. Details of instrument 50are shown in FIG. 8 . Forked tip 55 of the pusher 50 is employed forpushing the SutureLock™ anchor 90 into the bone socket or tunnel 30formed within bone 33 (i.e., pushing the FiberWire® suture 10 at aninsertion point where the TigerWire® suture 11 entered the FiberWire®suture 10).

FIG. 3 illustrates the tails of the TigerWire® suture 11 tensioned, to“accordionize” the FiberWire® and secure the SutureLock™ anchor 90within bone 33. The suture is flush with the bone 33 after tensioning.

FIG. 4 illustrates suture-based anchor 100 (ChainLock™ anchor 100)formed essentially of a suture chain 110 (such as FiberChain® orFiberLink™ 110) comprising a plurality of links having similar ordifferent diameters and lengths. A free end 111 of the FiberChain®suture 110 is first passed through the chain to form a closed suturechain loop 115. In an exemplary embodiment only, the free end 111 ispassed through every other link in the chain, with a graft preparationneedle, for example. When the free end 111 is tightened (as shown inFIG. 5 ), the loop 115 collapses in an accordion-like fashion withlaterally-projecting links to produce an interference fit. The loop 115is closed down by pulling tension on the tail and this collapses thelink like an accordion, forming the ChainLock™ anchor.

A flexible strand 120 (for example, a slide suture such as a FiberWire®suture or TigerWire® suture) is threaded through a middle link of theaccordion. Strand 120 will act as the sliding suture for tissue fixationafter the suture-based anchor 100 is placed into bone. Once theChainLock™ anchor 100 is inserted into the bone socket/tunnel, thesliding suture 120 (FiberWire® suture) is tensioned so that the tail ofthe FiberChain® suture is flush with the bone after tensioning.

FIG. 5 illustrates the suture-based anchor 100 (ChainLock™ anchor) withthe sliding suture 120 (FiberWire® suture 120) threaded through a middlelink and with one tail 111 of the suture chain 110 tensioned. FIG. 6illustrates the suture-based anchor 100 (ChainLock™ anchor)inserted/pushed into bone socket or tunnel 30 with a pusher (aring-handed instrument) 50 having a ring 52 and a tip 55. Details ofinstrument 50 are shown in FIG. 8 . Forked tip 55 of the pusher 50 isemployed for pushing the suture/FiberChain® into the bone socket ortunnel 30 formed within bone 33.

FIG. 7 illustrates the suture-based anchor 100 (ChainLock™ anchor) withthe tail of the suture chain 110 tensioned, to accordionize thesuture-based anchor 100 (ChainLock™ anchor) and to tighten thecircle/loop 115, so that the suture chain 110 is flush with the bone 33after tensioning. The two tails of sliding suture 120 ensure tissuefixation after the suture-based anchor 100 is placed within the bonetunnel/socket 30.

FIGS. 9-12 illustrate a suture-based anchor (TapeLock™ anchor) 200according to another exemplary embodiment of the present invention.Suture-based anchor 200 (TapeLock™ anchor 200) is formed essentially ofa suture tape 210, such as, for example, a FiberTape® suture 210. Suturetape 210 has a first length L1, a width W and a thickness (now shown).

As illustrated in FIG. 9 , flexible strand 220 (for example, a suturesuch as a FiberWire® or TigerWire® suture 220) is passed through alength of the FiberTape® 210 (with a needle, for example) such that theFiberWire® 220 circles back to exit through the FiberTape® 210 near thespot where it entered, creating a loop 215 that penetrates the tape in a“sine-wave” configuration. The flexible strand 220 (FiberWire® suture220) may be passed through the tape 210 at different locations and asdesired, for example, at predetermined insertion points on the length ofthe suture tape 210 (such as four locations, for example), which may beequally spaced from each other or from at least some of the remaininginsertion points, or which may not be equally spaced relative to theother insertion points. The end of the TigerWire® suture 220 is broughtback to reenter the FiberTape 210 near the spot where it first entered,to close the FiberTape® 210 and form closed loop 215.

FIG. 10 shows how the tensioning the two free ends of the FiberWire®suture 220 tightens the loop 215 and “accordionizes” the suture tape 210(to achieve a length L2 smaller than the length L1), creating expansionof the TapeLock anchor 200 to create an interference fit (i.e.,achieving expansion in a transversal orientation relative to thelongitudinal axis of the bone tunnel/socket). The TapeLock™ anchor 200is inserted into a bone socket/tunnel 30 (as shown in FIG. 11 )employing a pusher 50 (a ring-handed instrument) provided with a ring 52and a forked tip 55. Forked tip 55 of the pusher 50 is employed forpushing the TapeLock™ anchor 200 into the bone socket or tunnel 30formed within bone 33 (i.e., pushing the FiberTape® 210 at an insertionpoint where the TigerWire® suture 220 entered the tape).

FIG. 12 illustrates the tails of the FiberWire® suture 220 tensioned, to“accordionize” the FiberTape® and secure the TapeLock™ anchor 200 withinbone 33. The suture tape is flush with the bone 33 after tensioning. TheTapeLock™ anchor 200 having the expanded/accordion shape (in thedeployed or accordionized position) is captured below the corticalsurface of the bone to achieve fixation within the bone socket/tunnel30.

Although the suture-based anchors 90, 100, 200 have been described abovewith two free suture ends for tying knots, the suture-based anchors ofthe present invention could be also provided as knotless sutureconstructs. If a knotless suture construct is desired, a knotlessembodiment may be created by splicing a coreless suture (for example, acoreless FiberWire® suture) on the end of the anchor. This corelessFiberWire® suture would have a mechanism similar to that of an ArthrexACL Tightrope® (like a Chinese finger-trap). The coreless suture may bethreaded back through, as detailed below with reference to FIGS.13(a)-(d) and FIGS. 14(a)-(e), which depict subsequent steps of twomethods of self-reinforcing knotless fixation of soft tissue with thesoft anchors of the present invention (for example, the suture-basedanchors) and according to two exemplary methods of knotless fixation ofthe present invention.

FIGS. 13(a)-(d): Soft suture anchor 90 is inserted into bonesocket/tunnel 30 by employing pusher 50, for example. Suture anchor 90is also provided with two limbs, limb #1 and limb #2, of which one limb(for example, limb #1) is passed through soft tissue 88. A threader 92(for example, a flexible nitinol threader 92) is employed to thread limb#1 through about the center of limb #2 and for a predetermined length,for example, for about 5 mm (FIG. 13(a)). This will lock the suture by afinger-trap mechanism (FIG. 13(b)). The limb is pulled to tighten theloop (FIG. 13(c)). The suture is then cut close to the loop and thesutured tissue 88.

FIGS. 14(a)-(e): an alternative self-reinforcing knotless fixation withthe suture-based anchors of the present invention. A suture is threadedthrough suture for about 4 mm, to form the double-looped construct withloop #1 (10 a) and loop #2 (10 b) shown in FIG. 14(a). Pull-cord #1 andpull-cord #2 extend between the saddle 15 of the loop assembly. Thedouble-looped construct is similar to a finger-trap mechanism and isself-locking by pulling the two pull-cords.

Loop #2 is shuttled through soft tissue 88 as shown in FIG. 14(b). Bypulling on pull-cords #1 and #2, the saddle 15 of the loop assembly 10a, 10 b is pre-positioned within one loop of the soft anchor'saccordion.

Outside of the working cannula 85, separate sutures are used to tie loop#1 (10 a) and loop #2 (10 b) together, to create closed loop down to thepull-cords (FIG. 14(c)). Subsequently, the pull-cords are pulled tobring the loops down tightly over the soft tissue 88. The self-lockingand self-reinforcing finger-trap mechanism occurs at point A of FIG.14(d). The construct is tightened by pulling on the pull-cords. FIG.14(e) shows final knotless construct 90 a with the pull-cords cut flushwith bone 33.

The flexible strands employed for the formation of the suture-basedanchors 90, 100, 200, 90 a may be high-strength sutures, such as thehigh strength suture sold by Arthrex, Inc. of Naples, Fla. under theregistered tradename TigerWire® or FiberWire®, which is disclosed andclaimed in U.S. Pat. No. 6,716,234, the entire disclosure of which isincorporated herein by reference. FiberWire® suture is formed of anadvanced, high-strength fiber material, namely ultrahigh molecularweight polyethylene (UHMWPE), sold under the tradenames Spectra(Honeywell) and Dyneema (DSM) fibers, braided with at least one otherfiber, natural or synthetic, to form lengths of suture material. Thepreferred FiberWire® suture includes a core within a hollow braidedconstruct, the core being a twisted yarn of UHMWPE.

The suture tape employed for the formation of suture anchor 200 may be aFiberTape® as disclosed in U.S. Pat. No. 7,892,256, the disclosure ofwhich is herein incorporated by reference. The suture tapes may have thesame, uniform width or may have different widths, and may comprise thesame or different materials.

Although the terms “chain,” “suture chain” and FiberChain® have beenused interchangeably in this application, it must be understood that theterm “chain” is not limited to only “suture chain” or FiberChain®;rather, the term “chain” encompasses a plurality of loops of anymaterial and of any dimension (i.e., loops of similar or differentdiameters), as long as the loops are interconnected to each other. Anexemplary suture chain that may be used in the present application isdescribed in U.S. Pat. No. 7,803,173 and/or in U.S. Patent Appl. Publ.No. 2007/0135843, the disclosures of both of which are incorporated byreference in their entirety herewith.

The flexible material forming the suture anchors 90, 100, 200, 90 a maybe also formed of suture tape or a combination of suture and tape, astiff material, or combination of stiff and flexible materials,depending on the intended application.

FIGS. 15-21 illustrate another exemplary embodiment of a soft anchor 300of the present invention. Anchor 300 is a folding tube suture anchorwhich may be formed of textile or homogenous material (no sheath) andwhich does not have any “hard” surfaces. As shown in FIGS. 15 and 16 ,folding tube suture anchor 300 is formed of a tube (cylinder) 310provided with apertures/holes 311 to allow a flexible strand 320 to passtherethrough. When the tube is inserted into a bone tunnel/socket andwhen tension is applied, the tube 310 folds and lodges into the bonetunnel/socket. The distance between two adjacent apertures/holes 311 maybe the same or different.

FIGS. 17-21 illustrate subsequent steps of folding the tube anchor 300of FIG. 15 .

FIG. 17 : Inserter 350 (pulling here just to be out of the way) and blueFiberWire® suture 320 in loaded position using TigerWire® suture 360keep assembly tight and loaded, adjacent bone tunnel/socket 30 in bone33.

FIG. 18 : Inserter 350 “pushes” the assembly 300 into the pilot hole(but only as deep as desired ending position).

FIG. 19 : The TigerWire® suture 360 is removed and the anchor 300 isready to be deployed (inserter 350 is still “pushing” the anchor intothe pilot hole).

FIG. 20 : The blue FiberWire® suture 320 is pulled (will slide just likea normal anchor) to create a “folding” effect (the inserter 350 is still“pushing” the anchor 300 into the pilot hole).

FIG. 21 : Once the anchor 300 is folded, the inserter 350 is removed asthe anchor 300 is fixed into place in bone tunnel/socket 30.

FIGS. 22-40 illustrate soft anchor implants 400 a, 400 b, 400 c(accordion anchors 400 a, 400 b, 400 c) for tissue repairs (for example,soft tissue repairs such as PASTA repairs (Partial Articular-SidedTendon Avulsion repairs)) according to yet additional embodiments of thepresent invention. As detailed below, these soft anchor implants aresmaller than the conventional bone anchors (which are relatively large)and are formed of a soft (suture-based) material (in contrast to theconventional anchors which are typically formed of hard materials suchas PEEK, PLLA, bTCP, metal, PGA, biomaterials, etc.). The soft anchorimplants 400 a, 400 b, 400 c detailed below may be employed inpercutaneous insertions by simple surgical techniques, with multipleadditional indications, to provide biomechanically strong constructs.

FIGS. 22-24 illustrate exemplary soft anchor implants 400 a (implant A),400 b (implant B), 400 c (implant C), respectively, of the presentinvention. Soft anchor 400 a of FIG. 22 is a suture tape/core sutureconstruct. Soft anchor 400 b of FIG. 23 is a two anchor construct. Softanchor 400 c of FIG. 24 is a loop anchor construct.

FIG. 25 illustrates soft anchor implant 400 a (implant A) formed of asuture tape 410 (for example, a FiberTape®) which has a length offlexible strand 420 (for example, a suture core such as a #2 FiberWire®core) incorporated therein (i.e., extending within the body of thesuture tape or on the outside of the suture tape). A small knot 421 istied at one end of the flexible strand 420 (and of the end of the tape410) so that, when the suture core (FiberWire® core) 420 is pulled atthe other end, the suture tape 410 bunches up (folds up) similarly tothe bellows of an accordion. The bunched-up suture tape 410 becomes thesoft anchor 400 a of the present invention.

As detailed below, implants 400 b and 400 c are similar to the implant400 a in that they are also formed essentially of a suture tape (aFiberTape®) 410 with a flexible strand (a FiberWire® core) 420incorporated through the suture tape (i.e., extending throughout thelength of the suture tape and within the body of the suture tape, orsecured on the outside of the suture tape).

FIGS. 26(a)-(c) depict the formation of soft anchor implant 400 a(implant A). The implant is passed through an exemplary piece ofcardboard. The core suture 420 of the implant is then pulled so that theknot 421 at the end of the tape 410 helps the suture tape 410 bunch updown to the cardboard. The tape will completely bunch up underneath thecardboard.

FIGS. 27-33 (a) and (b) illustrate additional views of the soft anchorimplant 400 a (implant A) and methods of tissue fixation.

FIG. 27 : Soft anchor implant 400 a (implant A) consists essentially ofa continuous piece (strand) of suture tape 410 (FiberTape® 410) with alength of approximately 5 cm, of which about 2 cm will be buried intobone on either side of the suture tape. About 1 cm of the suture tape(i.e., the remaining length located in between the 2 cm sides that areburied into bone) acts as a “bridge” over the tissue to be repaired (forexample, a torn rotator cuff). The Fiberwire® core 420 (preferably a #2Fiberwire® suture) is pulled out the middle of the suture tape 410. Asmall knot 421 is tied in the end of each core suture 420.

FIG. 28 : Each tape end is loaded onto an inserter device 450 (describedin more details in FIGS. 40-42 ) and punched through the tissue (therotator cuff) and into the bone 33 to a depth of about 2 cm. Each core420 is then pulled causing the suture tape 410 to become “bunched up”inside the bone, thus securing the implant 400 a inside the bone.

FIG. 29 : A marking pen may be employed to mark the 2 cm intermedullaryportions 415 of the suture tape 410 of the implant 400 a.

FIG. 30 : The implant punctures the tissue (exemplary cardboard) and the2 cm intermedullary portions 415 of the suture tape 410 are insertedthrough the tissue (exemplary cardboard).

FIG. 31 : Pull on the core sutures 420 to deploy the implant 400 a.

FIG. 32 : The implant is seen from the top—the bridge of suture tape 410extends across the tissue (i.e., the rotator cuff or the exemplarycardboard).

FIGS. 33(a) and (b): The core sutures 420 are tied to one another tosecure the bridge of suture tape 410 on top of the tissue (i.e., on topof the rotator cuff or the exemplary cardboard). The anchors aredeployed underneath the bridge and the tissue, and the bridge is seen ontop of the tissue.

FIGS. 34 and 35 illustrate implant 400 a of the present inventionemployed in an exemplary tissue repair, i.e., a PASTA repair (PartialArticular-Sided Tendon Avulsion repair), which is typically consideredto be a challenging trans-tendon rotator cuff repair that requirespassing sutures through the rotator cuff and large implants of about 4.5to about 5.5 mm. FIG. 35 depicts a PASTA repair with two anchors 400 aof the present invention, for large legions (only one anchor may be usedfor small lesions).

FIG. 35 illustrates a first anchor 400 a inserted percutaneously throughthe rotator cuff and down into the bone. Moving over into thesubacromial (SA) space, a second anchor 400 a is inserted into the boneby first penetrating the rotator cuff. The second anchor is secured intothe bone by pulling on the core suture to deploy the anchor (i.e., tobunch up the suture tape within the tunnel/socket in the bone). The coresutures 420 from the two anchors 400 a are then tied together over therepair and on top of the cuff (to compress the PASTA lesion to theprepared bone bed).

FIGS. 36-38 illustrate implant 400 b of the present invention employedin another exemplary tissue repair according to the present invention.Implant 400 b consists of two separate soft anchors (FiberTape®anchors). Each anchor consists essentially of a length of suture tape (aFiberTape®) 410 of about 2 cm with a suture core (a #2 FiberWire® core)420 extending therethrough. When the anchor is deployed, the 2 cmFiberTape® will be buried into bone together with the knot 421 (formedas in implant 400 a). The suture core 420 is used for the repair.

FIGS. 37 and 38 illustrate both anchors of implant 400 b pierced throughexemplary tissue (i.e., cardboard and clover leaf). By pulling on thecore sutures 420, each of the anchors is deployed into the bone. Thecore sutures 420 are then tied together on top of the tissue, to securethe construct.

FIG. 39 illustrates implant 400 c which is a modified FiberTape® anchorthat consists essentially of a length of suture tape (FiberTape®) 410 ofabout 2 cm with a suture core 420 (for example, #2 FiberWire® core 420)extending therethrough and forming a loop 422 within the body of thesuture tape 410 (or securely attached to the outside of the body of thesuture tape). Implant 400 c is about similar to implant 400 b but differin that the core suture 420 is looped into the FiberTape® anchor. Eachimplant 400 c (anchor 400 c) may be about 2 cm in length. When the #2FiberWire® core suture is pulled, the FiberTape® anchor bunches up(i.e., deploys or accordionizes). Since no knot is present, the loopedcore suture can slide within the implant 400 c. The core sutures 420 areused for repair.

The accordion anchors 400 a, 400 b, 400 c detailed above have increasedpull-out strength (dramatically stronger compared to the strength ofcurrent suture anchors known in the art), and offer the followingadvantages:

No permanent solid anchor is present;

If implant gets loose, there is no hard abrasive surface to do damage tothe surrounding structures;

No bone/anchor cyst reaction;

Easy revision if necessary;

Provides broad area of issue compression via the suture tape;

Allows for scans/MRI—no scatter;

Diminishes the permanent stress riser;

Porous nature of the soft anchors 400 a, 400 b, 400 c allows forvigorous bone ingrowth into the FiberTape® anchor pores—the FiberTape®may be coated with collagen and/or other tissue growth-promotingcompositions and materials such as hyaluronic acid, for example; and

Bone marrow contents can easily seep up through the soft anchor into therepair site thus enhancing healing.

FIGS. 40-42 (a) and (b) illustrate details of an exemplary insertiondevice 450 which may be used to secure soft suture implants (such as,for example, the soft suture implants 90, 100, 200, 90 a, 400 a, 400 b,400 c of the present invention). The insertion device 450 may beprovided preloaded with an accordion anchor (such as anchor 400 a, forexample) or with multiple accordion anchors. The insertion device 450may have the configuration of a sharp spear with a sharp tip thatcreates the bone tunnel/socket for anchor insertion. The insertiondevice 450 may have the shape of a small needle (for example, an 18gauge needle, or about 1.6 mm) provided with a groove 456 at the neckwhere the anchor knot 421 fits. In an exemplary embodiment, and as shownin FIG. 40 , the anchor wraps circumferentially around the shaft of theinserter 450.

As shown in FIG. 40 , spikes 466 on the inserter may point down (i.e.,in a direction from top to bottom relative to a longitudinal axis of thedevice) to push the FiberTape® into bone (but without catching andpulling the FiberTape® out when the inserter is removed). Core sutureknot 421 rests (fits into) the groove 456 in the inserter. The sharpspear tip 460 creates the bone tunnel for anchor insertion. The insertermay be provided with at least one marking line 480 to indicate how farto insert the FiberTape®. Red markings on the FiberTape® may be used toensure that an appropriate length of the FiberTape® has been inserted.

FIGS. 41 and 42 illustrate the insertion device 450 without a preloadedanchor and showing the plurality of downward projecting spikes 466provided on the inserter body, to allow griping of the suture tape(FiberTape®) of the soft implant during insertion. As the inserter 450is pulled out, the spikes 466 “let go” of the soft anchor 400 a.Preferably, the spikes 466 are very shallow to avoid creating undofriction during anchor insertion. The design of the spikes mimics how arasp creates friction in one direction with minimal friction in theopposite direction.

FIGS. 42(a) and (b) illustrate how each anchor could be loaded on aseparate insertion spear to obtain anchor/insertion device assembly 500.If multiple insertion devices/spears 450 are used, the spears 450 couldbe loaded into a gun-type device such as, for example, the Arthrex“Meniscal Cinch” device. For example, FIGS. 43 and 44 illustrate a spear451 from a meniscal cinch assembly that pushes implant B (anchor 400 b)into the bone.

The accordion anchors 400 a, 400 b, 400 c detailed above may be alsoemployed with a self cinching suture mechanism that could beincorporated into the implant/anchor. Once the anchor is deployed, thesurgeon would simply pull on the self-cinching suture strands to firmlysecure the device and compress the tissue (for example, the rotatorcuff). The accordion anchors 400 a, 400 b, 400 c could be utilized formultiple additional indications such as, for example, AC jointreconstruction (as shown in FIG. 45 , wherein the #2 FiberWire® coresutures are passed through the coracoid and clavicle and then tied overa button having a dog-bone configuration), syndesmosis reconstruction,quad/patellar tendon rupture repair, hallux-valgus repair, and any othertendon repair to bone.

As shown in FIG. 45 , the accordion anchor 400 a (the FiberTape® anchor)is employed in an exemplary AC joint reconstruction method with afixation device 503 (button 503) having a specific “dog-bone-shape”configuration, as detailed and described in U.S. Patent ApplicationPublication No. 2012/0150203, the disclosure of which is incorporated byreference in its entirety herewith. The #2 FiberWire® core sutures 420are passed through tunnels 515, 525 in the coracoid 511 and clavicle 522(for example, small 2 mm tunnels), and then tied over the dog-bonebutton 503, to accordionize the tape and form the accordion anchor atthe base of the coracoid.

The accordion anchors 400 a, 400 b, 400 c detailed above may be alsoemployed in conjunction with additional various knotted and/or knotlessfixation devices (or combination of such knotted and knotless fixationdevices), such as PushLock® anchors and/or SwiveLock® anchors to secure,for example, a medial row on rotator cuff repairs.

While the present invention is described herein with reference toillustrative embodiments for particular applications, it should beunderstood that the invention is not limited thereto. Those havingordinary skill in the art and access to the teachings provided hereinwill recognize additional modifications, applications, embodiments andsubstitution of equivalents all fall within the scope of the invention.Accordingly, the invention is to be limited not by the specificdisclosure herein, but only by the appended claims.

What is claimed is:
 1. An anchor construct comprising: a bone anchorconfigured to be anchored in a bone socket, tunnel, or other crevice;and a suture threadable through or around tissue for holding the tissueagainst bone, wherein the suture extends from a first end of the boneanchor to an opposite second end of the bone anchor and comprises afirst section and a second section that both extends away from the firstend of the bone anchor while another part of the suture between thefirst and second sections is exposed to the outside of the bone anchorat the second end of the bone anchor, wherein the second section has alength, two apertures at different locations along the length, and achannel extending through the length to connect the two apertures;wherein in a first configuration, the bone anchor is anchored in thebone socket, tunnel, or other crevice while the channel of the sutureremains free from any other portion of the suture passing therethrough,and wherein in a second configuration, the first section of the sutureis passed through the channel to form a splice and an adjustableknotless self-locking loop adjacent the splice for securing the tissuewithin the loop.
 2. The anchor construct of claim 1, further comprisinga threader that is separable from the suture.
 3. The anchor construct ofclaim 2, wherein in the first configuration, the threader extendsthrough the channel of the second section of the suture.
 4. The anchorconstruct of claim 2, wherein the first section of the suture isconnectable to a first end of the threader.
 5. The anchor construct ofclaim 4, wherein the first end of the threader comprise a closed loop.6. The anchor construct of claim 1, wherein the bone anchor is a softanchor comprising a separate second suture.
 7. The anchor construct ofclaim 1, wherein the channel of the suture defines a coreless portion ofthe suture configured to form the splice.
 8. The anchor construct ofclaim 1, wherein the suture connects to the bone anchor at or near thesecond end of the bone anchor.
 9. The anchor construct of claim 8,wherein the suture wraps around at least part of the bone anchor at ornear the second end of the bone anchor.
 10. An anchor constructcomprising: a bone anchor configured to be anchored in a bone socket,tunnel, or other crevice, and a suture threadable through or aroundtissue for holding the tissue against bone, wherein the suture extendsfrom a first end of the bone anchor to an opposite second end of thebone anchor and comprises a first section and a second section that bothextend away from the first end of the bone anchor while another part ofthe suture between the first and second sections is exposed to theoutside of the bone anchor at the second end of the bone anchor, whereinthe second section has a length, two apertures at different locationsalong the length, and a channel extending through the length to connectthe two apertures; wherein in an initial configuration, the bone anchoris anchored in the bone socket, tunnel, or other crevice, the boneanchor is the only bone anchor through which the suture extends, and thechannel of the suture remains free from any other portion of the suturepassing therethrough; and wherein in a second configuration, the firstsection of the suture is passed through the channel of the suture toform a splice and an adjustable knotless self-locking loop adjacent thesplice for securing the tissue within the loop, and wherein a portion ofthe suture that defines the channel forms at least part of the loop. 11.The anchor construct of claim 10, wherein when the adjustable knotlessself-locking loop is formed and when pressure is applied outwardly frominside the loop, the second section of the suture including the channelis tensioned in a first direction while a section of the suture that ispositioned in the channel is tensioned in a direction opposite the firstdirection by the pressure.
 12. The anchor construct of claim 10, whereinthe bone anchor is a soft anchor comprising a separate second suture.13. The anchor construct of claim 10, wherein the channel of the suturedefines a coreless portion of the suture configured to form the splice.14. The anchor construct of claim 10, further comprising a threader thatis separable from the suture.
 15. The anchor construct of claim 14,wherein in the initial configuration, the threader extends through thechannel of the second section of the suture, and wherein the firstsection of the suture is connectable to a first end of the threader. 16.The anchor construct of claim 10, wherein the suture is configured toremain free from direct connections with any other bone anchors when theanchor construct is implanted.
 17. The anchor construct of claim 10,wherein the suture connects to the bone anchor at or near the second endof the bone anchor.
 18. The anchor construct of claim 17, wherein thesuture wraps around at least part of the bone anchor at or near thesecond end of the bone anchor.
 19. An anchor construct comprising: abone anchor configured to be anchored in a bone socket, tunnel, or othercrevice; and a suture threadable through or around tissue for holdingthe tissue against bone, wherein the suture extends from a first end ofthe bone anchor to an opposite second end of the bone anchor andcomprises a first section that extends away from the first end of thebone anchor, and a second section having a length, two apertures atdifferent locations along the length, and a channel extending throughthe length to connect the two apertures; wherein in a firstconfiguration, the bone anchor is anchored in the bone socket, tunnel,or other crevice while the channel of the suture remains free from anyother portion of the suture passing therethrough, and wherein in asecond configuration, the first section of the suture is passed throughthe channel to form a splice and an adjustable knotless self-lockingloop adjacent the splice for securing the tissue within the loop, andwherein the anchor is a soft anchor comprising a separate second suture.